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Article: Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B

TitlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
Authors
Issue Date2004
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217 How to Cite?
Abstract
BACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society
Persistent Identifierhttp://hdl.handle.net/10722/43076
ISSN
2013 Impact Factor: 54.420
ISI Accession Number ID

 

Author Affiliations
  1. Papageorgiou General Hospital
  2. The University of Hong Kong
  3. Ospedale Maggiore Policlinico Milano
  4. Beijing Youan Hospital
  5. Ankara Üniversitesi
  6. Hospital General Universitario de Valencia
  7. National Taiwan University Hospital
  8. Università degli Studi di Cagliari
  9. Songklanakarin Hospital
  10. Ruijin Hospital
  11. Henry Dunant Hospital
  12. Hopital Beaujon
  13. Uludağ Üniversitesi
DC FieldValueLanguage
dc.contributor.authorMarcellin, Pen_HK
dc.contributor.authorLau, GKen_HK
dc.contributor.authorBonino, Fen_HK
dc.contributor.authorFarci, Pen_HK
dc.contributor.authorHadziyannis, Sen_HK
dc.contributor.authorJin, Ren_HK
dc.contributor.authorLu, ZMen_HK
dc.contributor.authorPiratvisuth, Ten_HK
dc.contributor.authorGermanidis, Gen_HK
dc.contributor.authorYurdaydin, Cen_HK
dc.contributor.authorDiago, Men_HK
dc.contributor.authorGurel, Sen_HK
dc.contributor.authorLai, MYen_HK
dc.contributor.authorButton, Pen_HK
dc.contributor.authorPluck, Nen_HK
dc.date.accessioned2007-03-23T04:38:19Z-
dc.date.available2007-03-23T04:38:19Z-
dc.date.issued2004en_HK
dc.identifier.citationNew England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/43076-
dc.description.abstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Societyen_HK
dc.format.extent122021 bytes-
dc.format.extent3155 bytes-
dc.format.mimetypeapplication/pdf-
dc.format.mimetypetext/plain-
dc.languageengen_HK
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.en_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subject.meshAntiviral agents - adverse effects - therapeutic useen_HK
dc.subject.meshHepatitis b, chronic - blood - drug therapy - virologyen_HK
dc.subject.meshInterferon alfa-2a - adverse effects - therapeutic useen_HK
dc.subject.meshLamivudine - adverse effects - therapeutic useen_HK
dc.subject.meshPolyethylene glycols - adverse effects - therapeutic useen_HK
dc.titlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0028-4793&volume=351&issue=12&spage=1206&epage=1217&date=2004&atitle=Peginterferon+alfa-2a+alone,+lamivudine+alone,+and+the+two+in+combination+in+patients+with+HBeAg-negative+chronic+hepatitis+Ben_HK
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.doi10.1056/NEJMoa040431-
dc.identifier.pmid15371578en_HK
dc.identifier.scopuseid_2-s2.0-4544239807-
dc.identifier.hkuros100589-
dc.identifier.isiWOS:000223861300009-

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